Computer System Validation for Project Managers -- CS301
unique focus on Project Manager roles
Managing projects is a pretty tough assignment. Plan, manage, motivate, track, report, anticipate, fight fires …you know what’s expected. But when you’re managing a computer system validation project, it also means working closely and cooperatively with the quality group and doing your work to a level of detail necessary to satisfy the requirements of the FDA.
This course focuses on the role of Project Manager in a computer system validation project. Building on your knowledge of project management and computer system validation, this workshop explores the unique challenges of a validation project.
Topics
- Assessing your own project management capabilities
- Understanding the demands of validation projects
- Project management essentials –planning and control focus
- Scaling your validation effort based on risk
- Keeping the project management, SDLC, and validation activities clear and coordinated
- Understanding where you are –tracking and reporting your testing progress
- Key regulation and enforcement trends
Who Should Attend?
- Project Managers
- Validation Team Leads
- PMO Managers
- IT Managers
- Quality Assurance Managers
Prerequisites: Assumes knowledge of computer system validation and project management
Text/Materials Included: Course binder
Duration: 2 day workshop
Professional Development Credits: 16 PDUs
Cost: $1,850
Course Dates and Location:
There are currently no scheduled course dates. Please contact us if you are interested in enrolling in this class.